職業發展
Project Manager, Pharmacology & Toxicology Safety
Position: Pharmacology & Toxicology Safety
Location: Beijing

Job Description:

To propose safety and non-clinical strategies to support non-clinical development of drug candidates successfully IND/NDA filing.
Define study requirements and coordinate appropriate non-GLP and GLP Tox in non-clinical project development in accordance with the Health Authorities requirement; contribute to the design of non-clinical study; identify potential project hurdles and suggest solutions.
Contribute expert input into regulatory documents including investigator brochures, clinical study protocols and Development Safety Update Report within agreed timelines; Prepare, compile, and review appropriate sections of registration documents; represent Non-clinical in interactions with health authorities and external partners.
To coordinate cross-functional effort in planning budgets, timelines and resource allocations.
To monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams.
To participate in and contribute to the feasibility assessment of proposed new projects and ventures during the project evaluation process.
Performs other related duties as assigned.
 
Requirement:
Master of pharmacology degree or above in biochemistry, biology, DMPK preferably pharmacology and toxicology, 5 years+ of experience in pharmaceutical industry
Previous experience in new drug development
In-depth knowledge of non-clinical toxicology (in vitro and in vivo), SOP, guidelines and GLP principles is must
Fluent in oral English and effective communication
Strategic thinking and good planning skills
Performance driven
Self-motivated and able to motivate the team
 
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